Duloxetine Side Effects
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Duloxetine Safety Reports reported to FDA
Total Duloxetine reports: 144.Duloxetine FDA safety alerts: 2005 .
Reported deaths: 17 Reported hospitalizations: 71.
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Reported Duloxetine Side Effects: nausea, dizziness, suicide attempt, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, convulsion, loss of consciousness, syncope, akathisia, tremor.
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Duloxetine Side Effects Report #5154256-0Consumer or non-health professional from DENMARK reported DULOXETINE problem on Nov 07, 2006. Female patient, 36 years of age, weighting 149.9 lb, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: blood thyroid stimulating hormone increased, burning sensation, constipation, fatigue, flatulence, hypothyroidism, weight increased. DULOXETINE dosage: 30 MG, DAILY (1/D). Patient recovered.
Duloxetine Side Effects Report #5154266-3
DULOXETINE problem was reported by a Physician from NETHERLANDS on Oct 11, 2006. Female patient, 88 years of age, weighting 127.9 lb, was diagnosed with depression, hypertension, dyspepsia and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction. DULOXETINE dosage: 60 MG, UNK. During the same period patient was treated with ADALAT, METOPROLOL, RAMIPRIL, OMEPRAZOLE, TEMAZEPAM, NOVOMIX. Patient died on 05/23/2006.
Duloxetine Side Effects Report #5157590-3
Physician from HUNGARY reported DULOXETINE problem on Oct 26, 2006. Female patient, 30 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with MIANSERIN, MIRTAZAPINE, NEURO, XANAX, RIVOTRIL. Patient recovered.
Duloxetine Side Effects Report #5158682-5
DULOXETINE problem was reported by a Physician from GREECE on Nov 16, 2006. Female patient, 26 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: amnesia. DULOXETINE dosage: unknown. During the same period patient was treated with ZYPREXA. Patient recovered.
Duloxetine Side Effects Report #5162983-4
Physician from LEBANON reported DULOXETINE problem on Nov 03, 2006. Female patient, 30 years of age, was diagnosed with major depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: agitation, depressive symptom, hostility, insomnia, irritability, pyloric stenosis, suicide attempt. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with XANAX. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5164868-6
DULOXETINE problem was reported by a Physician from LEBANON on Nov 21, 2006. Female patient, 40 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction. DULOXETINE dosage: 60 MG, DAILY (1/D). Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5164873-X
Physician from reported DULOXETINE problem on Sept 08, 2006. Female patient, 75 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: depression, suicidal ideation. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with ZOLOFT, ZYBAN. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5170213-2
DULOXETINE problem was reported by a Physician from GREECE on Nov 16, 2006. Female patient, 26 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: amnesia. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with ZYPREXA. Patient recovered.
Duloxetine Side Effects Report #5171722-2
Physician from LEBANON reported DULOXETINE problem on Nov 21, 2006. Female patient, 52 years of age, was diagnosed with major depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with RISPERDAL. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5173724-9
DULOXETINE problem was reported by a Physician from LEBANON on Nov 03, 2006. Female patient, 30 years of age, was diagnosed with major depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: agitation, condition aggravated, depressive symptom, gastric haemorrhage, hostility, insomnia, irritability, overdose, pyloric stenosis. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with XANAX. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5190441-X
Physician from DENMARK reported DULOXETINE problem on Dec 14, 2006. Female patient, 50 years of age, was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: cerebral thrombosis, hemiplegia. DULOXETINE dosage: 30 MG, DAILY (1/D). During the same period patient was treated with TEMGESIC. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5190442-1
DULOXETINE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 14, 2006. Male patient, 53 years of age, was diagnosed with depression, pain, infection and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: device related infection, hypernatraemia, lactic acidosis, serotonin syndrome. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with PREGABALIN, BUPROPION, OXYCODONE, HYDROMORPHONE, VANCOMYCIN, PROPOFOL, LORAZEPAM, CYCLOBENZAPRINE. Patient recovered.
Duloxetine Side Effects Report #5193803-X
Physician from UNITED STATES reported DULOXETINE problem on Dec 18, 2006. Female patient, 55 years of age, was diagnosed with pain and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: renal failure, sepsis, serotonin syndrome. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with DULOXETINE HYDROCHLORIDE, FENTANYL, GABAPENTIN, ALENDRONATE, BACLOFEN, FLUCONAZOLE, FUROSEMIDE. Patient died.
Duloxetine Side Effects Report #5195590-8
DULOXETINE problem was reported by a Pharmacist from UNITED STATES on Dec 26, 2006. Male patient, 61 years of age, weighting 276.0 lb, was diagnosed with affective disorder, neuropathy and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: rash pruritic. DULOXETINE dosage: 30 MG DAILY PO. Patient recovered.
Duloxetine Side Effects Report #5195669-0
Physician from UNITED STATES reported DULOXETINE problem on Dec 22, 2006. Female patient, 19 years of age, weighting 244.0 lb, was diagnosed with major depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, pancreatitis acute. DULOXETINE dosage: 90 MG QD ORAL. During the same period patient was treated with ZOSYN, POTASSIUM CHLORIDE, DEMEROL, PROMETHAZINE, VICODIN ES, PRILOSEC, ALBUTEROL. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5385838-9
DULOXETINE problem was reported by a Physician from PORTUGAL on June 29, 2007. Male patient, 55 years of age, weighting 165.3 lb, was diagnosed with bipolar i disorder, bipolar disorder, akathisia and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: akathisia, suicide attempt. DULOXETINE dosage: 60 MG, EACH MORNING. During the same period patient was treated with ZYPREXA, DIAZEPAM, AKINETON, FLURAZEPAM. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5385853-5
Consumer or non-health professional from DENMARK reported DULOXETINE problem on July 02, 2007. Female patient, 29 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: depressive symptom, dizziness, influenza like illness, loss of consciousness, nausea, syncope. DULOXETINE dosage: 30 MG, UNK. During the same period patient was treated with DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE. Patient recovered.
Duloxetine Side Effects Report #5389693-2
DULOXETINE problem was reported by a Physician from UNITED STATES on July 05, 2007. Female patient, 42 years of age, weighting 188.5 lb, was diagnosed with back pain, prophylaxis, osteoarthritis and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, muscular weakness, syncope. DULOXETINE dosage: UNK MG, UNK. During the same period patient was treated with ADVIL, ASPIRIN, GLUCOSAMINE W. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5389695-6
Physician from JAPAN reported DULOXETINE problem on July 06, 2007. Male patient, 63 years of age, weighting 118.8 lb, was diagnosed with diabetic neuropathy, type 2 diabetes mellitus, angina pectoris, constipation, diabetic nephropathy, ischaemic heart disease prophylaxis and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: brain stem haemorrhage. DULOXETINE dosage: 20 MG, DAILY (1/D). During the same period patient was treated with DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, NOVORAPID, ISOSORBIDE MONONITRATE, PURSENNID, LASIX, TICLOPIDINE, ASPIRIN. Patient was hospitalized. Patient died on 05/18/2007.
Duloxetine Side Effects Report #5393407-X
DULOXETINE problem was reported by a Consumer or non-health professional from UNITED STATES on July 20, 2007. Female patient, 42 years of age, was diagnosed with major depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: urinary retention. DULOXETINE dosage: 60 MG DAILY PO. During the same period patient was treated with BACITRACIN, BUPROPION, CITALOPRAM HYDROBROMIDE. Patient recovered.
Duloxetine Side Effects Report #5396936-8
Physician from GREECE reported DULOXETINE problem on July 11, 2007. Female patient, 17 years of age, was diagnosed with panic disorder and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: aggression, anxiety, cyclothymic disorder, irritability. DULOXETINE dosage: 120 MG, DAILY (1/D). During the same period patient was treated with DULOXETINE HYDROCHLORIDE. Patient recovered.
Duloxetine Side Effects Report #5396948-4
DULOXETINE problem was reported by a Physician from AUSTRIA on July 12, 2007. Female patient, weighting 143.3 lb, was diagnosed with back pain and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: convulsion, loss of consciousness, nausea. DULOXETINE dosage: 60 MG, DAILY (1/D). Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5398118-2
Physician from PORTUGAL reported DULOXETINE problem on July 16, 2007. Male patient, 55 years of age, weighting 165.3 lb, was diagnosed with bipolar i disorder, bipolar disorder, akathisia and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: akathisia, suicide attempt. DULOXETINE dosage: 60 MG, EACH MORNING. During the same period patient was treated with ZYPREXA, DIAZEPAM, AKINETON, FLURAZEPAM, ZOLPIDEM TARTRATE, ANTIHYPERTENSIVES. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5400715-2
DULOXETINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 17, 2007. Female patient was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: convulsion, dyslexia, hemiparesis, muscle spasms, nausea, paraesthesia, tremor, vomiting. DULOXETINE dosage: 60 MG, ONE CAPSULE ONLY TAKEN. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5401206-5
Physician from NORWAY reported DULOXETINE problem on July 09, 2007. Female patient, 48 years of age, was diagnosed with depression, obesity and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: convulsion, nausea, palpitations, paraesthesia, vision blurred, visual disturbance. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with REDUCTIL. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5401713-5
DULOXETINE problem was reported by a Physician from GREECE on July 19, 2007. Male patient, 50 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: heart rate decreased. DULOXETINE dosage: 30 MG, DAILY (1/D). Patient recovered.
Duloxetine Side Effects Report #5404560-3
Physician from reported DULOXETINE problem on July 19, 2007. Female patient, 72 years of age, was diagnosed with depression, hypothyroidism, angiopathy and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, haemoglobin decreased, hypervitaminosis, platelet count decreased, red blood cell count decreased, refractory anaemia. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with EUTIROX, TICLOPIDINE, LORAZEPAM. Patient recovered.
Duloxetine Side Effects Report #5404561-5
DULOXETINE problem was reported by a Physician from PORTUGAL on July 19, 2007. Female patient, 23 years of age, was diagnosed with depression, epilepsy and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: epilepsy. DULOXETINE dosage: 60 MG, DAILY (1/D). During the same period patient was treated with CLONAZEPAM. Patient recovered.
Duloxetine Side Effects Report #5406486-8
Physician from NETHERLANDS reported DULOXETINE problem on July 23, 2007. Male patient, 43 years of age, weighting 222.7 lb, was diagnosed with back pain and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: hypertensive encephalopathy. DULOXETINE dosage: unknown. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5406873-8
DULOXETINE problem was reported by a Consumer or non-health professional from DENMARK on July 24, 2007. Female patient, 29 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: depressive symptom, dizziness, influenza like illness, loss of consciousness, nausea. DULOXETINE dosage: 30 MG, UNK. During the same period patient was treated with DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE. Patient recovered.
Duloxetine Side Effects Report #5407158-6
Consumer or non-health professional from UNITED STATES reported DULOXETINE problem on Aug 03, 2007. Female patient, 46 years of age, weighting 175.0 lb, was diagnosed with anxiety, sleep disorder and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: legal problem. DULOXETINE dosage: unknown. During the same period patient was treated with DULOXETINE HYDROCHLORIDE. Patient recovered.
Duloxetine Side Effects Report #5413984-X
DULOXETINE problem was reported by a Physician from GERMANY on Aug 02, 2007. Male patient, 49 years of age, weighting 202.8 lb, was diagnosed with sleep disorder, depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: dizziness, fall, motor dysfunction, urinary retention. DULOXETINE dosage: 30 MG, DAILY (1/D). During the same period patient was treated with ZOPICLON, PROMETHAZINE. Patient was hospitalized. Patient died on 05/01/2007.
Duloxetine Side Effects Report #5418140-7
Physician from RUSSIAN FEDERATION reported DULOXETINE problem on Aug 03, 2007. Female patient, 22 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: hyperbilirubinaemia. DULOXETINE dosage: 120 MG, DAILY (1/D). During the same period patient was treated with AMITRIPTYLINE, DIPHENHYDRAMINE, METAMIZOL SODIQUE, DICLOFENACO. Patient recovered.
Duloxetine Side Effects Report #5418469-2
DULOXETINE problem was reported by a Physician from GERMANY on Aug 06, 2007. Female patient, 64 years of age, was diagnosed with bipolar i disorder and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood amylase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased. DULOXETINE dosage: 30 MG, DAILY (1/D). During the same period patient was treated with DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, ZOPIKLON. Patient recovered.
Duloxetine Side Effects Report #5419624-8
Physician from UNITED STATES reported DULOXETINE problem on Aug 07, 2007. Female patient, 42 years of age, weighting 188.5 lb, was diagnosed with back pain, prophylaxis, osteoarthritis and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, muscular weakness, syncope. DULOXETINE dosage: UNK MG, UNK. During the same period patient was treated with ADVIL, ASPIRIN, GLUCOSAMINE W. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5419625-X
DULOXETINE problem was reported by a Physician from JAPAN on Aug 06, 2007. Male patient, 63 years of age, weighting 176.4 lb, was diagnosed with diabetic neuropathy, thrombosis prophylaxis, type 2 diabetes mellitus and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: iiird nerve paralysis. DULOXETINE dosage: 20 MG, DAILY (1/D). During the same period patient was treated with DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, METHYCOBAL, ASPIRIN, HUMALOG, INNOLET N. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5423958-0
Physician from UNITED STATES reported DULOXETINE problem on Aug 13, 2007. Male patient, 49 years of age, weighting 191.0 lb, was diagnosed with social phobia and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, excessive exercise, infection, liver function test abnormal, oedema peripheral, rhabdomyolysis. DULOXETINE dosage: 60 MG, UNK. Patient recovered.
Duloxetine Side Effects Report #5429139-9
DULOXETINE problem was reported by a Physician from DENMARK on Aug 15, 2007. Female patient was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. DULOXETINE dosage: 60 MG, UNK. During the same period patient was treated with CONTRACEPTIVES NOS. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5441840-X
Physician from AUSTRIA reported DULOXETINE problem on Aug 21, 2007. Female patient, weighting 143.3 lb, was diagnosed with back pain and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: convulsion, loss of consciousness, nausea. DULOXETINE dosage: 60 MG, DAILY (1/D). Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5443258-2
DULOXETINE problem was reported by a Physician from RUSSIAN FEDERATION on Aug 22, 2007. Female patient, 22 years of age, was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: hyperbilirubinaemia. DULOXETINE dosage: 120 MG, DAILY (1/D). During the same period patient was treated with AMITRIPTYLINE, DIPHENHYDRAMINE, METAMIZOL SODIQUE, DICLOFENACO. Patient recovered.
Duloxetine Side Effects Report #5444523-5
Pharmacist from UNITED STATES reported DULOXETINE problem on Sept 04, 2007. Female patient, 89 years of age, weighting 96.78 lb, was diagnosed with dementia, depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: back pain, hypertensive crisis. DULOXETINE dosage: 30MG DAILY PO LESS THAN 5 MONTHS. During the same period patient was treated with ALENDRONATE, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5450186-5
DULOXETINE problem was reported by a Physician from JAPAN on Aug 31, 2007. Male patient, 63 years of age, weighting 176.4 lb, was diagnosed with diabetic neuropathy, thrombosis prophylaxis, type 2 diabetes mellitus and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: brain stem syndrome, diplopia, dizziness, headache, iiird nerve paralysis, nausea. DULOXETINE dosage: 20 MG, DAILY (1/D). During the same period patient was treated with DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, METHYCOBAL, ASPIRIN, HUMALOG, INNOLET N. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5467129-0
Pharmacist from UNITED STATES reported DULOXETINE problem on Sept 21, 2007. Male patient was diagnosed with depression and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: fall, inappropriate antidiuretic hormone secretion, mental status changes, walking aid user. DULOXETINE dosage: 30 MG DAILY PO. During the same period patient was treated with FORTICAL, LOTENSIN, ASPIRIN, LUNESTA, HYTRIN, COUMADIN, ACULAR. Patient was hospitalized. Patient recovered.
Duloxetine Side Effects Report #5470859-8
DULOXETINE problem was reported by a Physician from GERMANY on Sept 17, 2007. Male patient, 77 years of age, weighting 165.3 lb, was diagnosed with urinary incontinence and was treated with DULOXETINE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, dizziness. DULOXETINE dosage: unknown. During the same period patient was treated with RAMIPRIL, AMLODIPINE, ARICEPT. Patient recovered.
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Drug Information: Duloxetine
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a604030.html
(doo lox' e teen)IMPORTANT WARNING:
| A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as duloxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take duloxetine, but in some cases, a doctor may decide that duloxetine is the best medication to treat a child's condition.You should know that your mental health may change in unexpected ways when you take duloxetine or other antidepressants even if you are an adult over age 24. These changes may occur even if you do not have a mental illness and you are taking duloxetine to treat a different type of condition. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.Your healthcare provider will want to see you often while you are taking duloxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with duloxetine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf.No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you. |
Why is this medication prescribed?
Duloxetine is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer). Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (damage to nerves that can develop in people who have diabetes). Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.
How should this medicine be used?
Duloxetine comes as a delayed release (long-acting) capsule to take by mouth. When duloxetine is used to treat depression, it is usually taken once or twice a day with or without food. When duloxetine is used to treat generalized anxiety disorder or the pain of diabetic neuropathy, it is usually taken once a day with or without food. Take duloxetine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take duloxetine exactly as directed. Do not take more or less of it, take it more often, or take it for a longer time than prescribed by your doctor.
Swallow the capsules whole; do not split, chew, or crush them. Do not open the capsules and mix the contents with liquids or sprinkle the contents on food.
If you are taking duloxetine to treat generalized anxiety disorder or the pain of diabetic neuropathy, your doctor may start you on a low dose of medication and gradually increase your dose.
Duloxetine may help control your symptoms but will not cure your condition. It may take 1 to 4 weeks or longer before you feel the full benefit of duloxetine. Continue to take duloxetine even if you feel well. Do not stop taking duloxetine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking duloxetine, you may experience withdrawal symptoms such as dizziness, nausea, vomiting, headache, pain, burning or tingling in the hands or feet, irritability, and nightmares.Tell your doctor if you experience any of these symptoms when your dose of duloxetine is decreased.
Other uses for this medicine
Duloxetine is also sometimes used to treat stress urinary incontinence (leakage of urine during physical activity such as coughing, sneezing, laughing, and exercise) in women. Talk to your doctor about using this medication to treat your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking duloxetine,
- tell your doctor and pharmacist if you are allergic to duloxetine or any other medications.
- tell your doctor if you are taking thioridazine or a monoamine oxidase (MAO) inhibitor, such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take duloxetine. If you stop taking duloxetine, you should wait at least 5 days before you start to take an MAO inhibitor.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; cimetidine (Tagamet); diuretics ('water pills'); linezolid (Zyvox); medications for irregular heartbeat such as amiodarone (Cordarone), flecainide (Tambocor), moricizine (Ethmozine), quinidine (Quinidex) and propafenone (Rythmol); medications for anxiety, high blood pressure, mental illness, pain, and nausea; propranolol (Inderal); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); lithium (Eskalith, Lithobid); proton pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (Aciphex); quinolone antibiotics such as ciprofloxacin (Cipro) and enoxacin (Penetrex); sedatives; certain selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox) and paroxetine (Paxil); sibutramine (Meridia); sleeping pills; theophylline (Theochron, Theolair); tramadol (Ultram); and tranquilizers. Many other medications may interact with duloxetine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially products containing St. John's wort or tryptophan.
- tell your doctor if you have or have ever had glaucoma (an eye condition). Your doctor may tell you that you should not take duloxetine.
- tell your doctor if you drink or have ever drunk large amounts of alcohol or if you use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you have or have ever had a heart attack; high blood pressure; seizures; coronary artery disease (blockage or narrowing of the blood vessels that lead to the heart; or heart, liver, or kidney disease. If you have diabetes, be sure to talk to your doctor about how serious your condition is so your doctor can decide if duloxetine is right for you.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking duloxetine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking duloxetine.
- you should know that duloxetine may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
- ask your doctor about the safe use of alcoholic beverages while you are taking duloxetine..Alcohol can increase the risk of serious side effects from duloxetine.
- you should know that duloxetine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking duloxetine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Duloxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea
- vomiting
- constipation
- diarrhea
- heartburn
- stomach pain
- decreased appetite
- dry mouth
- increased urination
- difficulty urinating
- sweating or night sweats
- dizziness
- headache
- extreme tiredness
- weakness
- muscle pain or cramps
- changes in sexual desire or ability
- uncontrollable shaking of a part of the body
Some side effects can be serious. If you experience any of the following side effects, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
- unusual bruising or bleeding
- pain in the upper right part of the stomach
- itching
- yellowing of the skin or eyes
- dark colored urine
- flu-like symptoms
- blurred vision
- fever
- blisters
- rash
- hives
- swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
- difficulty breathing or swallowing
Duloxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- agitation
- hallucinating (seeing things or hearing voices that do not exist)
- fast heartbeat
- fever
- loss of coordination
- nausea
- vomiting
- diarrhea
- drowsiness
- seizures
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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